Kendall 222002Recalls & reported problems
Cardinal Health 200, LLC · Kendall Prewired, Radiolucent, Neonatal Monitoring electrode · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20192253016625), received between Jun 27, 2024 and Jun 27, 2024 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blister1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER ADDITIONAL INFORMATION RECEIVED, THE BABY WAS IN AN INCUBATOR (TEMP 80.1F, 26.7C) PRIOR TO THE REPORTED INCIDENT. VASELINE WAS APPLIED AND THE WOUND WAS COVERED IN GAUZE. THERE WAS NO GROWTH, AND NO ANTIBIOTICS WERE GIVEN. THE DURATION OF THE ELECTRODE USE IS UNKNOWN, BUT THEY WERE AT LEAST CHANGED IN LESS THAN 48 HOURS.
Patient problems: Blister
MAUDE report 19629357 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.